Vimovo is a drug owned by Horizon Medicines Llc. It is protected by 22 US drug patents filed from 2013 to 2017. Out of these, 3 drug patents are active and 19 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 17, 2031. Details of Vimovo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8945621 | Method for treating a patient at risk for developing an NSAID-associated ulcer |
Oct, 2031
(6 years from now) | Active |
| US9220698 | Method for delivering a pharmaceutical composition to patient in need thereof |
Mar, 2031
(6 years from now) | Active |
| US9393208 | Method for delivering a pharmaceutical composition to patient in need thereof |
Sep, 2029
(4 years from now) | Active |
| US6926907 | Pharmaceutical compositions for the coordinated delivery of NSAIDs |
Feb, 2023
(1 year, 8 months ago) |
Expired
|
| US8557285 | Pharmaceutical compositions for the coordinated delivery of NSAIDs |
May, 2022
(2 years ago) |
Expired
|
| US8858996 | Pharmaceutical compositions for the coordinated delivery of NSAIDS |
May, 2022
(2 years ago) |
Expired
|
| US8852636 | Pharmaceutical compositions for the coordinated delivery of NSAIDs |
May, 2022
(2 years ago) |
Expired
|
| US9198888 | Pharmaceutical compositions for the coordinated delivery of NSAIDs |
May, 2022
(2 years ago) |
Expired
|
| US9161920 | Pharmaceutical compositions for the coordinated delivery of NSAIDs |
May, 2022
(2 years ago) |
Expired
|
| US9707181 | Pharmaceutical compositions for the coordinated delivery of NSAIDs |
May, 2022
(2 years ago) |
Expired
|
| US9345695 | Pharmaceutical compositions for the coordinated delivery of NSAIDs |
May, 2022
(2 years ago) |
Expired
|
|
US7411070 (Pediatric) | Form of S-omeprazole |
Nov, 2018
(5 years ago) |
Expired
|
|
US6369085 (Pediatric) | Form of S-omeprazole |
Nov, 2018
(5 years ago) |
Expired
|
| US7745466 | Form of S-omeprazole |
Oct, 2018
(6 years ago) |
Expired
|
| US6369085 | Form of S-omeprazole |
May, 2018
(6 years ago) |
Expired
|
| US7411070 | Form of S-omeprazole |
May, 2018
(6 years ago) |
Expired
|
|
US5900424 (Pediatric) | Omeprazole magnesium salt form |
Nov, 2016
(8 years ago) |
Expired
|
| US5900424 | Omeprazole magnesium salt form |
May, 2016
(8 years ago) |
Expired
|
|
US5714504 (Pediatric) | Compositions |
Aug, 2015
(9 years ago) |
Expired
|
| US5714504 | Compositions |
Feb, 2015
(9 years ago) |
Expired
|
|
US6875872 (Pediatric) | Compounds |
Nov, 2014
(9 years ago) |
Expired
|
| US6875872 | Compounds |
May, 2014
(10 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Vimovo's patents.
Latest Legal Activities on Vimovo's Patents
Given below is the list of recent legal activities going on the following patents of Vimovo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jan, 2024 | US9393208 |
| Expire Patent Critical | 08 Jan, 2024 | US9198888 |
| Expire Patent Critical | 27 Nov, 2023 | US9161920 |
| Maintenance Fee Reminder Mailed Critical | 24 Jul, 2023 | US9198888 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Jun, 2023 | US9220698 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 12 Jun, 2023 | US9161920 |
| Expire Patent Critical | 21 Nov, 2022 | US8858996 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Aug, 2022 | US8945621 (Litigated) |
| Expire Patent Critical | 01 Aug, 2022 | US7745466 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 06 Jun, 2022 | US8858996 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vimovo and ongoing litigations to help you estimate the early arrival of Vimovo generic.
Vimovo's Litigations
Vimovo been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 24, 2015, against patent number US8557285. The petitioner Dr. Reddy's Lab., Inc., challenged the validity of this patent, with Pozen Inc. as the respondent. Click below to track the latest information on how companies are challenging Vimovo's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9220698 | April, 2018 |
Terminated
(09 Sep, 2019) | Horizon Pharma USA, Inc. et al. | Dr. Reddy's Laboratories, Inc. |
| US9393208 | December, 2017 |
Final Written Decision
(06 Sep, 2019) | Horizon Pharma USA, Inc. et al. | Mylan Pharmaceuticals Inc. et al. |
| US9393208 | July, 2018 |
Terminated
(01 Apr, 2019) | Pozen Inc. et al. | Dr. Reddy's Lab., Inc. et al. |
| US9220698 | August, 2017 |
Terminated
(27 Mar, 2019) | Horizon Pharma USA, Inc. et al. | Mylan Pharmaceuticals Inc. et al. |
| US8858996 | August, 2015 |
Final Written Decision
(28 Feb, 2017) | Pozen Inc. et al. | Lupin Pharmaceuticals Inc. et al. |
| US8945621 | August, 2015 |
FWD Entered
(21 Feb, 2017) | Pozen Inc | Coalition for Affordable Drugs VII LLC |
| US8852636 | August, 2015 |
Terminated-Denied
(01 Mar, 2016) | Pozen Inc. | Lupin Pharmaceuticals Inc |
| US8852636 | August, 2015 |
Terminated-Denied
(11 Feb, 2016) | Pozen Inc. | Coalition for Affordable Drugs VII LLC |
| US8858996 | June, 2015 |
Terminated-Denied
(17 Dec, 2015) | Pozen Inc. | Coalition for Affordable Drugs VII LLC |
| US6926907 | May, 2015 |
Terminated-Denied
(08 Dec, 2015) | POZEN Inc. | Coalition for Affordable Drugs VII LLC |
| US8557285 | February, 2015 |
Terminated-Denied
(09 Oct, 2015) | Pozen Inc. | Dr. Reddy's Lab., Inc. |
FDA has granted some exclusivities to Vimovo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vimovo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vimovo.
Exclusivity Information
Vimovo holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Vimovo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Apr 30, 2013 |
| New Patient Population(NPP) | Jul 06, 2020 |
Several oppositions have been filed on Vimovo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Vimovo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vimovo patents.
Vimovo's Oppositions Filed in EPO
Vimovo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 15, 2011, by Strawman Limited. This opposition was filed on patent number EP02734602A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP02734602A | Apr, 2011 | CHATFIELD PHARMACEUTICALS LIMITED | Patent maintained as amended |
| EP02734602A | Apr, 2011 | STRAWMAN LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Vimovo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vimovo's family patents as well as insights into ongoing legal events on those patents.
Vimovo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vimovo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 17, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vimovo Generic API suppliers:
Esomeprazole Magnesium; Naproxen is the generic name for the brand Vimovo. 6 different companies have already filed for the generic of Vimovo, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vimovo's generic
How can I launch a generic of Vimovo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vimovo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vimovo's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Vimovo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 375 mg/20 mg and 500 mg/20 mg | 05 Nov, 2010 | 1 | 28 Feb, 2023 | Extinguished |
About Vimovo
Vimovo is a drug owned by Horizon Medicines Llc. It is used for relieving symptoms of arthritis and reducing the risk of NSAID-associated gastric ulcers. Vimovo uses Esomeprazole Magnesium; Naproxen as an active ingredient. Vimovo was launched by Horizon in 2010.
Approval Date:
Vimovo was approved by FDA for market use on 30 April, 2010.
Active Ingredient:
Vimovo uses Esomeprazole Magnesium; Naproxen as the active ingredient. Check out other Drugs and Companies using Esomeprazole Magnesium; Naproxen ingredient
Treatment:
Vimovo is used for relieving symptoms of arthritis and reducing the risk of NSAID-associated gastric ulcers.
Dosage:
Vimovo is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE | Discontinued | ORAL |
| EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE | Discontinued | ORAL |